Frozen Human Serum

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Q&A - Amendment III - The purpose of amendment III is to respond to industry inquiries.

Question: Will the Government grant an extension on the quotation due date?

Response: No.

Question: Will the Government provide donor eligibility criteria (inclusion and exclusion) to guid the recruitment and selection of sample donors?

Response: No additional donor eligibility criteria is provided outside of the CLSI 37-A guidelines, which have been updated and published (Clin Chem Lab Med. 2020 Feb 25;58(3):368-374. doi: 10.1515/cclm-2019-0732)

Question: Does the Government require donors to be treatment-naive, or is concomitant treatment acceptable?

Response: There is no requirement for donors to be treatment-naive.

Question: Does the Government have any restrictions on including donors with bone caners or any genetic conditons that may affect bone density?

Response: No

Question: Does the Government have any restrictions on countries where the serum samples may be collected?

Response: No

Question: Does the Government have a preferred blood collection tube for use to collect the whole blood samples for serum separation?

Response: Yes, the CLSI 37-A protocol requires that individual donor units of whole blood are collected using industry-standard empty blood-packs with integral donor tube, a 15-gauge needle, and a 600-mL plastic container (blood bag must be immersed in ice-water slurry during the procedure) (Clin Chem Lab Med. 2020 Feb 25;58(3):368-374. doi: 10.1515/cclm-2019-0732) Collection tubes cannot be used for collection or serum separation.

Question: Will the Government provide any initial reference material to guide the pooling and validation of vitamin D metabolites?

Response: No. Reference materials for vitamin D metabolites in serum are available for sale if needed by a lab for validation.

Question: Will the Government provide the CLSI C37-A Guidelines for reference?

Response: No. The original CLSI C37-A is copyright protected and cannot be provided by NIST. It must be obtained from CLSI. An updated version of the protocol is published in the open literature (Clin Chem Lab Med. 2020 Feb 25;58(3):368-374. doi: 10.1515/cclm-2019-0732)

Question: Can the Government clarify what certifications are necessary for the laboratories performing the biosafety tests, vitamin D analysis, serum pooling, and aliquoting?

Response: No specific certifications are necessary for the laboratories performing the biosafety tests and vitamin D analysis. The safety tests used must be licensed by the US FDA. The laboratory performing the serum pooling and aliquoting must be certified to ISO 13485.

Question: Can the Government clarify the acceptable number of freeze-thaw cycles that the serum samples may undergo prior to final aliquoting and storage?

Response: The serum samples can be freeze-thawed once prior to pooling. The thawing must occur immediately prior to pooling.

Question: Does the Government have a specific process in place for identifying, approving, and procuring an alternative to the Voigt Global (#72413S-3) vials in the event that they are unavailable?

Response: No.

Question: Can the Government allow flexibility on the 240-day delivery timeline in the event of IRB/ethics approval delays?

Response: No.

Question: Will the samples and data deliverables be submitted in batches, or must all samples and data be finalized and submitted together?

Response: The samples and data deliverables can be submitted in batches, but the material cannot be accepted until all deliverables are received and evaluated by NIST. Samples and data can be submitted all at once.

Question: Does the Government have a limit on the volume of whole blood that can be collected from each individual donor?

Response: No.

Question: Does the Government have any restrictions on eligible donors donating blood at multiple time points?

Response: No.

Question: Does the Government require ISO 13485:2016 certification for the laboratory that performsserum sample processing (pooling, aliquoting, and storage) and the laboratory that performs vitamin D analysis, if performed by different laboratories?

Response: ISO 13485 certification is required by the processing laboratory. If the vitamin D analysis is subcontracted, the subcontracted laboratory does not need to be ISO 13485 certified. The vitamin D analysis laboratory is only required to operate a measurement platform that can quantify 25(OH)D2 and 25(OH)D3 separately.

Question: Does the Government require samples to be tested on an ISO certified vitamin D test platform?

Response: No.

All other terms and conditions remain unchanged, as a result of this amendment.

Q&A - Amendment II - The purpose of amendment II is to respond to industry inquiries.

Question: Is accreditation as a Certified Reference Material producer required? We have ISO 13485, but the term "Certified Reference Material" is often associated with a different standard.

Response: No, NIST is the Certified Reference Material (CRM) producer. The vendor would be provideing the material and NIST is responsible for converting it to a CRM. The ISO 13485 requirement is sufficient for the vendor.

Question: Is filling/capping under nitrogen required?

Response: Yes.

Question: Is a storage condition of -60C sufficient?

Response: No. Storage conditions of -80 degrees C are required to maintain stability.

Question: The requirement states each unit of single-donor serum shall be analyzed to ascertain the 25(OH)D2, 25(OH)D3, and total 25(OH)D concentrations. Is it acceptable for only the pooled matrix to be analyzed to ascertain the 25(OH)D2, 25(OH)D3, and total 25(OH)D concentrations?

Response: While NIST is mainly concerned with the 25(OH)D2, 25(OH)D3, and total 25(OH)D concentrations of the pooled materials for each level, we expect that the vendor would need to screen a significant number of single-donor serum for 25(OH)D2 and 25(OH)D3 to design the pools to obtain the specific targets for each.

Question: Would this be a one-time order, or will you be intending to reorder this?

Response: This would be a one-time order. NIST does not anticipate procuring a smiliar material for at least another five (5) years.

All other terms and conditions remain unchanged, as a result of the amendment.

Q&A - Amendment I - The purpose of amendment I is to respond to an industry inquiry.

Question: The description states crimp vials with 4 different color crimp seals. We do not use crimp seals much anymore and I’m not even sure we can get them in 4 different colors. Are screw cap vials acceptable?

Response: No, screw cap vials are not acceptable.

All other terms and conditions remain unchanged, as a result of this amendment.

COMBINED SYNOPSIS/SOLICITATION 1333ND25QNB640292

SRM 972b Vitamin D Metabolites in Frozen Human Serum

This is a combined synopsis/solicitation for commercial items prepared in accordance with the

format in FAR Subpart 12.6- Streamlined Procedures for Evaluation and Solicitation for Commercial

Items, as supplemented with additional information included in this notice. This announcement

constitutes the only solicitation; quotations are being requested, and a separate written

solicitation document will not be issued. This solicitation is being issued under the authority of

FAR Part 13, Simplified Acquisition Procedures.

This solicitation is a Request for Quotation (RFQ). The solicitation document and incorporated

provisions and clauses are those in effect through the Federal Acquisition Circular (FAC) 2025-04

effective 6/11/2025.

The associated North American Industrial Classification System (NAICS) code for this procurement is

325414, with a small business size of 1,250 employees. This acquisition will use Small Business

Set-Aside procedures.

The National Institute of Standards & Technologies Organic Chemical Metrology Group requires Frozen

Human Serum Standard Reference Material (SRM) 972b, in accordance with the attached

Statement of Requirements.

Attachments/Links